Understanding and addressing socio-cultural barriers to medical male circumcision in traditionally non-circumcising rural communities in sub-Saharan Africa.

Given recent clinical trials establishing the safety and efficacy of adult medical male circumcision (MMC) in Africa, attention has now shifted to barriers and facilitators to programmatic implementation in traditionally non-circumcising communities. In this study, we attempted to develop a fuller understanding of the role of cultural issues in the acceptance of adult circumcision. We conducted four focus-group discussions with 28 participants in Mutoko, Zimbabwe, and 33 participants in Vulindlela, KwaZulu-Natal, South Africa, as well as 19 key informant interviews in both settings. We found the concept of male circumcision to be an alien practice, particularly as expressed in the context of local languages. Cultural barriers included local concepts of ethnicity, social groups, masculinity and sexuality. On the other hand, we found that concerns about the impact of HIV on communities resulted in willingness to consider adult male circumcision as an option if it would result in lowering the local burden of the epidemic. Adult MMC-promotional messages that create a synergy between understandings of both traditional and medical circumcision will be more successful in these communities.

Motivators and Barriers for Parents to Disclose their HIV Status to Children.

Disclosure to children has been identified as one of the main challenges for parents living with HIV (PLH). The aim of this study was to qualitatively explore motivators, barriers, and the process of parental disclosure in a Zimbabwean community with high HIV prevalence. A total of 28 PLH participated in three focus groups comprising PLH who had disclosed their HIV status to their children (n = 11), PLH who had not disclosed to their children (n = 7), and the third group contained PLH who both had and had not disclosed their status (n = 10). Full, partial and indirect disclosure approaches were used by parents. Barriers to disclosing included the children being "too young" and lacking understanding of HIV as well as inability to maintain confidentiality around parents' status, 2) causing the child to worry, 3) being embarrassed, and 4) fearing that disclosure would prompt a child to treat a parent with disrespect. Motivators included 1) support of various kinds from their children, 2) educating their children around HIV risk, and 3) facilitating discussions about parental illness and death. Our findings suggest that understanding the barriers to disclosure is likely insufficient for supporting and promoting parental disclosure. The motivation for disclosure, support for the disclosure process, and culturally relevant interventions are needed to promote and support parental disclosure.

No "magic bullet": exploring community mobilization strategies used in a multi-site community based randomized controlled trial: Project Accept (HPTN 043).

As community-level interventions become more common in HIV prevention, processes such as community mobilization (CM) are increasingly utilized in public health programs and research. Project Accept, a multi-site community randomized controlled trial, is testing the hypothesis that CM coupled with community-based mobile voluntary counseling and testing and post-test support services will alter community norms and reduce the incidence of HIV. By using a multiple-case study approach, this qualitative study identifies seven major community mobilization strategies used in Project Accept, including stakeholder buy-in, formation of community coalitions, community engagement, community participation, raising community awareness, involvement of leaders, and partnership building, and describes three key elements of mobilization success.

NIMH Project Accept (HPTN 043) HIV/AIDS community mobilization (CM) to promote mobile HIV voluntary counseling and testing (MVCT) in rural communities in Northern Thailand: modifications by experience.

Project Accept is a RCT designed to test the efficacy of community mobilization (CM), mobile voluntary counseling and testing (MVCT), and post-test support services (PTSS) in reducing HIV incidence in three African countries and Thailand. The intervention started in rural areas, northern Thailand in January 2006. CM initially included door-to-door visits during the daytime, small group discussions and joining organized meetings and followed by MVCT. In February 2007, CM strategy using HIV/AIDS "edutainment" (education and entertainment) during evening hours was introduced. After edutainment was initiated, the number of participants increased substantially. VCT uptake increased from 18 to 28 persons/day on average (t test; t = 7.87 P < 0.0001). Edutainment especially motivated younger people, as the median age of VCT clients decreased from 38 to 35 years old (median test; z = 6.74, P < 0.0001). Providing free MVCT in community settings along with edutainment during evening hours increased VCT uptake and was particularly attractive to younger adults.

Health diplomacy and the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: evaluating findings from Project Accept (HPTN 043).

BACKGROUND: Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of 'global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. METHODS: We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. RESULTS: Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of 'youth-friendly' services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). CONCLUSIONS: Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective.

Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

BACKGROUND: Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. METHODS: We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. RESULTS: During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. CONCLUSIONS: The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites ensures consistent and high quality delivery of all intervention components, in keeping with the goals of the study protocol, while also providing a forum for corrective feedback, additional supervision and retraining of staff. QAC ensures staff fidelity to study procedures and is critical to the successful delivery of multi-site HIV prevention interventions, as well as the delivery of services scaled up in programmatic situations.

Uptake and Outcomes Associated with Implementation of a Community-Based Voluntary HIV Counseling and Testing Program in Antigua and Barbuda.

OBJECTIVE: To evaluate the implementation of community-based voluntary HIV counseling and testing (CBVCT) in the Eastern Caribbean. METHODS: A total of 9782 unique HIV testing events performed through a national program of CBVCT in Antigua and Barbuda (2009-2012) were analyzed. The authors describe testers' demographic characteristics and assess demographic (education, housing, marital status, nationality, and age) and sexual exposure (partner gender, transactional sex, and multiple partners) factors associated with testing HIV-positivity and with condom use. RESULTS: Older men and men having sex with women and women with higher education, of Antiguan nationality, and having sex with men were less likely to test positive for HIV. Younger, educated, and unmarried men and women with multiple partners were more likely to report using condoms. CONCLUSION: The CBVCT model can be successfully implemented in Eastern Caribbean. Demographic differences persist in HIV testing, risk behavior, and infection among vulnerable populations and should be considered in HIV prevention intervention design.

Association of negotiation strategies with consistent use of male condoms by women receiving an HIV prevention intervention in Zimbabwe.

One of the fundamental aspects of HIV counselling for women is condom negotiation strategy development. The present research sought to identify condom request strategies used by Zimbabwean women and to determine which were most effective in persuading male partners to use condoms. Of six types of strategies used by women after a prevention intervention, one was significantly associated with consistent condom use 2 months later. Implications for the development of counselling and testing protocols are discussed.

Vaginal microbicides for HIV/STI prevention in Zimbabwe: what key informants say.

The purpose of this study was to assess the acceptability of vaginal microbicides as prevention methods for heterosexually transmitted HIV. Interviews were conducted with key informants in and around Harare using a semistructured questionnaire with probes. Twenty-seven interviews were conducted with a total of 48 informants. Most women were enthusiastic about the products but had concerns about safety and how the use of these products might affect their relationships with their husbands. Many men were concerned that women would be able to use the products without their consent or knowledge. Several products may be acceptable in this culture but must be introduced within the existing gender power structure. This study provides a model for involving community leaders in the design of culturally appropriate clinical trials.

Informing comprehensive HIV prevention: a situational analysis of the HIV prevention and care context, North West Province South Africa.

OBJECTIVE: Building a successful combination prevention program requires understanding the community's local epidemiological profile, the social community norms that shape vulnerability to HIV and access to care, and the available community resources. We carried out a situational analysis in order to shape a comprehensive HIV prevention program that address local barriers to care at multiple contextual levels in the North West Province of South Africa. METHOD: The situational analysis was conducted in two sub-districts in 2012 and guided by an adaptation of WHO's Strategic Approach, a predominantly qualitative method, including observation of service delivery points and in-depth interviews and focus groups with local leaders, providers, and community members, in order to recommend context-specific HIV prevention strategies. Analysis began during fieldwork with nightly discussions of findings and continued with coding original textual data from the fieldwork notebooks and a select number of recorded interviews. RESULTS: We conducted over 200 individual and group interviews and gleaned four principal social barriers to HIV prevention and care, including: HIV fatalism, traditional gender norms, HIV-related stigma, and challenges with communication around HIV, all of which fuel the HIV epidemic. At the different levels of response needed to stem the epidemic, we found evidence of national policies and programs that are mitigating the social risk factors but little community-based responses that address social risk factors to HIV. CONCLUSIONS: Understanding social and structural barriers to care helped shape our comprehensive HIV prevention program, which address the four 'themes' identified into each component of the program. Activities are underway to engage communities, offer community-based testing in high transmission areas, community stigma reduction, and a positive health, dignity and prevention program for stigma reduction and improve communication skills. The situational analysis process successfully shaped key programmatic decisions and cultivated a deeper collaboration with local stakeholders to support program implementation.

Community-based intervention to increase HIV testing and case detection in people aged 16-32 years in Tanzania, Zimbabwe, and Thailand (NIMH Project Accept, HPTN 043): a randomised study.

BACKGROUND: In developing countries, most people infected with HIV do not know their infection status. We aimed to assess whether HIV testing could be increased by combination of community mobilisation, mobile community-based voluntary counselling and testing (VCT), and support after testing. METHODS: Project Accept is underway in ten communities in Tanzania, eight in Zimbabwe, and 14 in Thailand. Communities at each site were paired according to similar demographic and environmental characteristics, and one community from each pair was randomly assigned to receive standard clinic-based VCT (SVCT), and the other community was assigned to receive community-based VCT (CBVCT) plus access to SVCT. Randomisation and assignment of communities to intervention groups was done by the statistics centre by computer; no one was masked to treatment assignment because the interventions were community based. Intervention was provided for about 3 years (2006-09). The primary endpoint of HIV incidence is pending completion of assessments after the intervention. In this interim analysis, we examined the secondary endpoint of uptake in HIV testing, differences in characteristics of clients receiving their first HIV test, and repeat testing. Analyses were limited to clients aged 16-32 years. This study is registered with ClinicalTrials.gov, number NCT00203749. FINDINGS: The proportion of clients receiving their first HIV test during the study was higher in CBVCT communities than in SVCT communities in Tanzania (2341 [37%] of 6250 vs 579 [9%] of 6733), Zimbabwe (5437 [51%] of 10,700 vs 602 [5%] of 12,150), and Thailand (7802 [69%] of 11,290 vs 2319 [23%] 10,033). The mean difference in the proportion of clients receiving HIV testing between CBVCT and SVCT communities was 40·2% (95% CI 15·8-64·7; p=0·019) across three community pairs (one per country). HIV prevalence was higher in SVCT communities than in CBVCT communities, but CBVCT detected almost four times more HIV cases than did SVCT across the three study sites (952 vs 264; p=0·003). Repeat HIV testing in CBVCT communities increased in all sites to reach 28% of all those testing for HIV by the end of the intervention period. INTERPRETATION: CBVCT should be considered as a viable intervention to increase detection of HIV infection, especially in regions with restricted access to clinic-based VCT and support services after testing. FUNDING: US National Institute of Mental Health, HIV Prevention Trials Network (via US National Institute of Allergy and Infectious Diseases), and US National Institutes of Health.

Project Accept (HPTN 043): a community-based intervention to reduce HIV incidence in populations at risk for HIV in sub-Saharan Africa and Thailand.

BACKGROUND: Changing community norms to increase awareness of HIV status and reduce HIV-related stigma has the potential to reduce the incidence of HIV-1 infection in the developing world. METHODS: We developed and implemented a multilevel intervention providing community-based HIV mobile voluntary counseling and testing, community mobilization, and posttest support services. Forty-eight communities in Tanzania, Zimbabwe, South Africa, and Thailand were randomized to receive the intervention or clinic-based standard voluntary counseling and testing (VCT), the comparison condition. We monitored utilization of community-based HIV mobile voluntary counseling and testing and clinic-based standard VCT by community of residence at 3 sites, which was used to assess differential uptake. We also developed quality assurance procedures to evaluate staff fidelity to the intervention. FINDINGS: In the first year of the study, a 4-fold increase in testing was observed in the intervention versus comparison communities. We also found an overall 95% adherence to intervention components. Study outcomes, including prevalence of recent HIV infection and community-level HIV stigma, will be assessed after 3 years of intervention. CONCLUSIONS: The provision of mobile services, combined with appropriate support activities, may have significant effects on utilization of voluntary counseling and testing. These findings also provide early support for community mobilization as a strategy for increasing testing rates.

The importance of discreet use of the diaphragm to Zimbabwean women and their partners.

We conducted a 6-month acceptability study of diaphragms as a potential HIV/STI prevention method among Zimbabwean women. We examined partner involvement in diaphragm use, and importance of discreet use (use without partner awareness). Of the 181 women who completed the study, 45% said discreet use was "very or extremely important" and in multivariate logistic regression, women were more likely to value discretion if their partners: had other partners; drank alcohol; or were believed to prefer condoms to diaphragms. Qualitative data confirmed these findings. Both women and their partners reported that diaphragms can be used discreetly and saw this as advantageous, for both sexual pleasure and female control. However, many were concerned that use without partner approval could lead to marital problems. Discreet use should be considered in development of barrier methods and in diaphragm promotion, if proven effective against HIV/STI.

Removing barriers to knowing HIV status: same-day mobile HIV testing in Zimbabwe.

OBJECTIVES: We developed a mobile HIV voluntary counseling testing (VCT) strategy. Our aims were (1) to describe those using the services, (2) to assess the acceptability of such services, (3) to assess reasons for not testing previously, and (4) to compare those who used the services with those who did not to determine how to increase acceptability. METHODS: We provided free anonymous mobile VCT using 2 rapid HIV tests in 12 marketplaces in Epworth and Seke, Zimbabwe. Qualitative interviews were conducted to assess motivations for and barriers to testing. A subsample of HIV testers and individuals near testing vans who declined testing (nontesters) completed a questionnaire. RESULTS: A total of 1099 individuals participated in mobile VCT between March 2002 and August 2003. The proportion of participants infected with HIV was 29.2%. Overall, 98.8% of participants elected to receive HIV test results the same day. Reasons for not testing previously were often logistic (eg, inconvenience of hours [25.6%] and location [20.7%] or cost [8%]). Those who used the same-day mobile testing services (testers vs. nontesters) perceived themselves at higher risk for HIV infection (adjusted odds ratio [AOR] = 1.8) but were less likely to have known people with HIV (AOR = 0.49) or where to get tested (AOR = 0.57). CONCLUSIONS: Same-day HIV testing in community settings seems to be acceptable in sub-Saharan Africa. Barriers to HIV testing are often logistic and can be overcome with community-based strategies. These strategies need to be refined to address the needs of those not using mobile testing services.

Barrier method preferences and perceptions among Zimbabwean women and their partners.

In Zimbabwe, adult HIV prevalence is over 25% and acceptable prevention methods are urgently needed. Sixty-eight Zimbabwean women who had completed a barrier-methods study and 34 of their male partners participated in focus group discussions and in-depth interviews to qualitatively explore acceptability of male condoms, female condoms and diaphragms. Most men and about half of women preferred diaphragms because they are female-controlled and do not detract from sexual pleasure or carry stigma. Unknown efficacy and reuse were concerns and some women reported feeling unclean when leaving the diaphragm in for six hours following sex. Nearly half of women and some men preferred male condoms because they are effective and limit women's exposure to semen, although they reportedly detract from sexual pleasure and carry social stigma. Female condoms were least preferred because of obviousness and partial coverage of outer-genitalia that interfered with sexual pleasure.

Acceptability of a microbicide among women and their partners in a 4-country phase I trial.

OBJECTIVES: We analyzed qualitative and quantitative data for 98 HIV-negative, low-risk women in Malawi, Zimbabwe, India, and Thailand who participated in a safety and acceptability study of BufferGel, a vaginal microbicide to determine the across-country acceptability of vaginal microbicides among women and their partners. METHODS: Quantitative survey data were collected at 7 and 14 days after use among enrolled women, and exit interviews were conducted with women and their partners in separate focus group discussions. RESULTS: Acceptability was high in all sites (73% of women approved of the microbicide). Women in Africa, where HIV infection rates are highest, were virtually unanimous in their desire for such a product, suggesting that an individual's perception of being at risk for HIV will outweigh concerns about side effects, problems applying a product, or other factors, when products are shown to be efficacious. But men and women reported that use, which was kept secret from an intimate partner, would be difficult and might "break the trust" of a relationship. CONCLUSIONS: Acceptability research across diverse settings through all stages of microbicide research, development, and post-licensure dissemination can help maximize acceptability and use.